Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement

Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)

This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis, Severe
• Intervention / Treatment: Diagnostic test: TAVR planning

Detailed Description

A prospective study involving 11 patients referred for TAVR was conducted. A multidetector computed tomography (MDCT) was used to acquire and segment the anatomy of the access route and landing zone. From the information obtained with the MDCT in DICOM format, the investigators built a virtual platform (VisuaMed, Teacher Team. Valencia. Spain) that contains all the clinical information of the patients and a virtualized model of their anatomy. Wearing VR devices, the professional was able to "walk inside " the anatomy in an interactive and immersive way. Decisions after the evaluation of routine clinical images were compared with those after experience with VR models and intraprocedural findings.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • CentroMT (Centro Médico Teknon)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Severe aortic stenosis considered for TAVR procedure at a single Institution

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TAVR standard; TAVR planning evaluated without VR and TAVR planning after VR analysis	Diagnostic test: TAVR planning; TAVR planning without VR vs after VR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAVR procedure planning (prosthesis size, implant technique requirements, potential risks)	Does the TAVR procedure planning change after VR?	Baseline

Collaborators and Investigators

• Sponsor: Centro Medico Teknon
• Collaborators: Techer Team SL. Valencia. Spain

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: Cardiac Surgery CentroMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No